Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201505001146214 Date of Approval: 19/05/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title mixed agonist -antagonist protocol
Official scientific title mixed agonist -antagonist protocol in POR
Brief summary describing the background and objectives of the trial comparing novel mixed protocol versus standard agonist protocol and standard antagonist protocol in poor ovarian response undergoing ICSI cycles in mixed protocol we give agonist from day 21 of previous cycle to day1 of tretment cycle then start gonadotropin therapy then add antagonist at day 6 of treatment cycle
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied infertility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2015
Actual trial start date 31/12/2015
Anticipated date of last follow up 01/03/2016
Actual Last follow-up date 01/12/2015
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group long agonist protocol decapeptyl0.1mg 20days long agonist 100
Control Group antagonist 0.25mg cetrotide from D6 6 days average standrad antagonist 100 Active-Treatment of Control Group
Experimental Group mixed agonist -antagonist decapeptyl0.1mg 10 days and cetrotide 0.25 6days 10 +6 days mixed agonist -antagonist 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
bologna criteria of POR Nrmal responders PCO 35 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/05/2015 CUH ethical committee
Ethics Committee Address
Street address City Postal code Country
kasr alainy cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome CPR 6weeks gestation
Secondary Outcome ovulation induction day of HCG
Secondary Outcome IVF outcomes at day 3 of (ET)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university hospitals kasr alainy st cairo 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CUH kasr alainy cairo 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUH kasr alainy cairo 12613 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mohamed Awad 9 said zulfakar cairo 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com 00201111765934 24 abdelrahman elbarkoky
City Postal code Country Position/Affiliation
Cairo 12-613 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Awad m_oj_h@yahoo.com 00201005034393 9 said zulfakar
City Postal code Country Position/Affiliation
cairo 12613 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Awad m_oj_h@yahoo.com 00201005034393 9 said zulfakar
City Postal code Country Position/Affiliation
cairo 12613 Egypt Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information